After passing phase 2 clinical trials, companies need to prepare for phase 3 clinical trials, submission of a BLA/NDA/MAA and ultimately an FDA/EMA regulatory inspection.
ADRES is experienced in the inspection process and can ensure that your company is prepared.
Inspectors need to see every document concerning product development, and verify that all data within the submission file has gone through the process of source data verification. In addition, the inspectors will verify that all suppliers, CMOs, clinical sites, service providers, and analytical labs are in full compliance.
ADRES will get you ready for this critical milestone in the development of your product.